Clinical Operations Specialist 1

Job Title: Clinical Operations Specialist 1

Location: Irvine, CA

Pay Rate: $35 - $40/hr, W 2

Duration: 12+ Month Contract

Work Mode: On Site

Summary:

• Hours: Mon-Fri, 8am - 5pm

Responsibilities:

• Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines.
• Develop and execute device processes associated with clinical trials, ensuring compliance with regulations and managing the lifecycle of devices.
• Coordinate procurement of study inventory and manage shipment of devices to clinical sites within established timelines.
• Confirm receipt of study product at clinical sites and track product through to final disposition, ensuring required documentation is filed in the Trial Master File (TMF).
• Monitor internal device and study-specific inventory levels; support inventory forecasting and planning.
• Generate transparency reporting data and reports as needed to support Sunshine Act compliance.
• Track, manage, and coordinate clinical study invoice processing to ensure timely review, approval, and payment.
• Ensure documentation is stored and archived appropriately within record retention facilities.
• Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive.
• Support clinical research laboratory operations as needed.
• Other incidental duties as assigned to support clinical study operations.

Requirements:

• Minimum 2 years of clinical research experience.

Preferred Skills:

• Associate's/Bachelor’s degree in a related field.